These new provisions, which go into effect in two years, are designed to ensure a narrower range of potency of levothyroxine throughout its entire shelf life. Specifically, the FDA specifications say that levothyroxine sodium medications will need to maintain potency levels between 95 and 105 percent until their expiration date. This range is tighter than the current standard, which is a range of 90 to 110 percent potency.
The FDA has mandated these changes because they have found in recent surveys that levothyroxine potency is not stable. The FDA evaluated stability data for levothyroxine from all manufacturers, for drugs produced between July 2003 and June 2005. What they found was that the drugs tended to lose potency over time, and some were degrading quite quickly, and losing so much effectiveness that they were close to the 90% minimum potency level by the time they were close to expiration.
Other findings of the FDA:
- Some levothyroxine packaging -- blister packs, for example -- degrade more quickly than others.
- Some levothyroxine tablets were stable and lost less than 5 percent of their potency over a 2 year period, while others lost as much as 10 percent of labeled potency in just 9 months.
The FDA says that their new specifications will ensure that levothyroxine products are more stable, have less fluctuation in potency, and will limit the amount they can degrade over the entire shelf life. The ultimate goal is less variability in the products, which in turn, will help ensure more stable thyroid function for patients. This is, according to the FDA, especially important for thyroid cancer survivors, who require stable, suppressive doses of medication to prevent cancer recurrence.
The affected companies include all manufacturers of levothyroxine:
- Levolet, from Vintage (not marketed in the US)
- Levo-T, from Alara
- Levothroid, from Lloyd, distributed by Forest
- Levothyroxine Sodium, from Genpharm
- Levothyroxine Sodium, from Mylan
- Levoxyl, from Jones Pharma/King
- Synthroid, from Abbott
- Tirosint, from Institute Biochimique
- Unithroid, from Jerome Stevens
Implications and Recommendations for Patients
If you're a thyroid patient taking levothyroxine, this new requirement won't have any particular effect on you in the short term. You should continue taking your medication as prescribed by your practitioner.The FDA does advise, however, that to help ensure the best possible potency of your medication, you should store your levothyroxine drugs in a dry place, at room temperature. You should avoid humid or hot conditions -- that means, you should NOT store your levothyroxine in the bathroom. Summertime and hot climates -- as well as the popularity of mail order pharmacies -- raise additional issues. Find out important guidelines on how to protect your thyroid medication from heat damage.
The manufacturers have a two-year deadline to comply with these new specifications. According to the FDA, some of the products already meet the new potency specifications, and there won't be any changes to those products. Other products may have their expiration dates shortened, or may get new packaging to help extend shelf life. Some products may undergo some reformulating in order to improve stability. (I'm looking into whether the specific product data is available.)
